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FDA NDA · NDA219379

GOMEKLI

mirdametinib

Sponsor: SPRINGWORKS

APPLICATION
NDA219379
TYPE
NDA
ORIGINAL APPROVAL
2025-02-11
LATEST ACTION
2025-02-11
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

GOMEKLI · ReferencePrescription
MIRDAMETINIB 1MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2025-02-11Type 1 - New Molecular Entity · Original · priorityLabelAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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